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Набира участници Фаза 3 NCT06911502

A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Follicular Lymphoma

Спонсор: Celgene

Налично на: БГ
Обобщение
The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.
Кой може да участва
Inclusion Criteria: * Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted. * Relapsed or refractory disease: 1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy. 2. Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most recent prior therapy. * Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities). * Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification. * Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria. * Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility. * Lab parameters: 1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L), 2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L) 3. Hb ≥ 7.5 g/dL * estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m². * Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0× ULN. * Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group \[NCI ODWG\] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be ≤ 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin≤ 5.0 × ULN * Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA) Exclusion Criteria: * Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL) or any other indolent lymphoma. * Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL. * Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment. * Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment. * Presence or history of central nervous system (CNS) involvement by lymphoma. * History of stroke or intracranial hemorrhage within 6 months prior to enrollment. * Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment. * Participants with a history of progressive multifocal leukoencephalopathy. * Participant has any other subtype of lymphoma. * Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management. * History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 21
Австралия (1)
Westmead Hospital
Westmead , New South Wales
Amanda Johnston, Site 0134
Бразилия (1)
Local Institution - 0159
Vitória , Espírito Santo
NOT_YET_RECRUITING
Канада (1)
Local Institution - 0200
Victoria , British Columbia
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0154
Santiago , Santiago Metropolitan
NOT_YET_RECRUITING
Китай (1)
Local Institution - 0246
Beijing , Beijing Municipality
NOT_YET_RECRUITING
Финландия (1)
Local Institution - 0151
Oulu , North Ostrobothnia
NOT_YET_RECRUITING
Франция (1)
CHU Bordeaux Haut-Leveque
Pessac , Aquitaine
Francois-Xavier Gros, Site 0100
Германия (1)
Local Institution - 0163
Ulm , Baden-Wurttemberg
NOT_YET_RECRUITING
Гърция (1)
Local Institution - 0111
Alexandroupoli , Anatolikí Makedonía Kai Thráki
NOT_YET_RECRUITING
Индия (1)
Local Institution - 0139
Bengaluru , Karnataka
NOT_YET_RECRUITING
Италия (1)
Local Institution - 0104
Bologna , Emilia-Romagna
NOT_YET_RECRUITING
Япония (1)
Nagoya University Hospital
Nagoya , Aichi-ken
Kazuyuki Shimada, Site 0205
Нидерландия (1)
Amsterdam UMC, locatie VUmc
Amsterdam , North Holland
Sanne Tonino, Site 0050
Полша (1)
AIDPORT Sp. z o.o.
Skórzewo , Greater Poland Voivodeship
Michal Kwiatek, Site 0185
Saudi Arabia (1)
Local Institution - 0099
Dammam , Eastern Province
NOT_YET_RECRUITING
Южна Корея (1)
Local Institution - 0059
Seoul , Seoul-teukbyeolsi [Seoul]
NOT_YET_RECRUITING
Испания (1)
Hospital Universitari Parc Tauli
Sabadell , Barcelona [Barcelona]
Xavier Vilaseca Creus, Site 0158
Турция (1)
Local Institution - 0195
Istanbul- Fatih , Istanbul
NOT_YET_RECRUITING
United Arab Emirates (1)
Local Institution - 0251
Abu Dhabi , Abu Dhabi Emirate
NOT_YET_RECRUITING
Великобритания (1)
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cringleford , England
Joel Cunningham, Site 0148
САЩ (1)
Local Institution - 0225
Birmingham , Alabama
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.07.2025
Крайна дата
31.07.2030
Регистрационен номер
NCT06911502
Източник
anzctr
Запитване за медицински туризъм

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